N-[3-(dimethylamino)propyl]-N,N',N'-trimethylpropane-1,3-diamine

Endpoint summary

Description of key information

Oral LD50 = 1598 mg/kg
Inhalation LC50 = 1480 mg/m³
Dermal LD50 = 569 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study preceeds current OECD guidelines, however is equivalent to OECD Guideline 404 (Acute Dermal Irritation / Corrosion). No GLP, however the study is sufficiently reported and the results unambiguous.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Species:

other: Rat and Mouse

Route of administration:

oral: drinking water

Vehicle:

water

Control animals:

no

Sex:

male

Dose descriptor:

LD50

Effect level:

2.37 mL/kg bw

Based on:

test mat.

Remarks on result:

other: Male Rat

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 2.3 mL/kg bw

Based on:

test mat.

95% CL:

>= 2.09 - <= 2.51

Remarks on result:

other: Female rat

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 2.19 mL/kg bw

Based on:

test mat.

95% CL:

>= 1.97 - <= 2.46

Remarks on result:

other: Male Mouse

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 1.68 mL/kg bw

Based on:

test mat.

95% CL:

>= 1.49 - <= 1.87

Remarks on result:

other: Female Mouse

Mortality:

Obsrved in all treated groups.

Clinical signs:

other: Decreased activity, ataxia, dyspnea and writhing

Other findings:

Signs of toxicity were observed immediately after treatment and jpersisted les than 24 hours post-treatment (corrosive)

Interpretation of results:

moderately toxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Rat - Acute Oral Toxicity LD50 1598 mg/kg
The substance is severely irritating and corrosive to the skin and eyes. This material is irritating and corrosive to the nasal and respiratory tract

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 598 mg/kg bw

Quality of whole database:

Reliable with restrictions.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was not performd to GLP and reporting of methods is sparse. However, the study outcomes are unambiguous and predictable. Therefore the study is deeemd sufficiently reliable.

Qualifier:

no guideline followed

Principles of method if other than guideline:

Whole-body exposure.

GLP compliance:

not specified

Test type:

standard acute method

Species:

rat

Strain:

other: Charles River rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young adult albino rats were employed as test animals. The rats were selected after having been under observation for at least 5 days to insure their general health and suitability for testing. The animals were housed in stainless steel cages and permitted a standard laboratory diet plus .water
ad libitum, except during inhalation exposure.

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

clean air

Details on inhalation exposure:

Vapour was generated by passing a stream of clen, dry air through the diluted test material in a gas washing bottle. The resulting air/vapour mixture ws then introduced to the exposure chamber.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

ca. 14 d

Remarks on duration:

Whole-body exposure.

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Sex:

male/female

Dose descriptor:

LC50

Remarks on result:

other: No effects attributable to the test material were observed

Mortality:

None observed

Clinical signs:

other: None observed

Body weight:

No changes observerd outside of normal ranges

Gross pathology:

No gross effect reported

Interpretation of results:

sligthly toxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

There were no adverse reactions noted during exposure or the 14-day observaticn period which followed. The average 2- week body weight gains were within the normal limits.

The LC50 was calculated as >1.48 mg/L (rat) 1-hr. (no deaths)

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LC50

Value:

1 480

Quality of whole database:

Reliable with restrictions.

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was coinducted according to OECD Guideline 402 (Acute Dermal Toxicity). The substance was administered to five rats of each sex by dermal application.. NA GLP certificate is provided. The study is otherwise well documented.

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Species:

rat

Strain:

Wistar

Sex:

male/female

Type of coverage:

open

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The substance was administered to five rats of each sex by dermal application at 2000, 1000 or 400 mg.kg body weight for 24 hours.

Duration of exposure:

24 hours.

Doses:

Dermal application at 2000, 1000 or 400 mg.kg

No. of animals per sex per dose:

5 males
5 Females

Control animals:

not specified

Sex:

male

Dose descriptor:

LD50

Effect level:

1.2 mL/kg bw

Based on:

test mat.

95% CL:

>= 1.01 - <= 2.01

Sex:

male

Dose descriptor:

LD50

Effect level:

1.25 mL/kg bw

Based on:

test mat.

Mortality:

The incidence of mortality among both sexes from high to low dose group was 10, 10 and 0.

Clinical signs:

other: Hyperactivity and lethargy were noted in all animals. Prostration, bradypnoea, piloerection, ptosis, squealing and lacrimation were noted among the animals. These symptoms had disappeared in all surviving animals by day 5, although temporary piloerection

Gross pathology:

The treated skin surface among the animals showed oedema, necrosis, erythema, crusts, scaliness, a wound and new skin formation.
Macroscopic post iuortem examination of the animals that died during the study revealed greenish discolouration of the treated area, red spot in the treated area, dark redlblacklpurple colouration of the dermis beneath the treated
area, dark red colouration of the muscles under the treated area, black areas in glandular stomach, red coloured lungs and reddish liquid fn thoracic cavity. These findings were considered treatment related and toxicological significant.
Macroscopic post mortem examination of the surviving animals at termination revealed scab formation on the treated skin area, reduced seminal vesicles and thickened, grey, hard left testes grown together with the epididymis.

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 value in rats was determined to be 569 mg/kg bw for the sexes combined.
Due to the mortality distribution alone estimated dermal LD50 values could be calculated for males and females alone. These amounted to 569 mg/kg body weight for males alone and 569 mg/kg body weight for females alone.

Based on the results, and according to EU Directive 67/548/EEC, the substance should be classified as harmful.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

569 mg/kg bw

Quality of whole database:

Reliable with restrictions.

Additional information

The substance is severely irritating and corrosive to the skin and eyes. This material is irritating and corrosive to the nasal and respiratory tract.

Rat - Acute Oral Toxicity LD50 1598 mg/kg.

Justification for selection of acute toxicity – oral endpoint
In an acute oral toxicity study in rats, the substance was determined to have an Acute Oral LD50 of 1598 mg/kg.

Justification for selection of acute toxicity – inhalation endpoint
In a whole-body vapour inhalation test in rats, vapour was generated by passing a stream of clean, dry air through the diluted test material in a gas washing bottle. The resulting air/vapour mixture was then introduced to the exposure chamber.
After 1 hour no deaths were reported.
The LC50 was determined as >1.48 mg/L (rat) 1-hr. (no deaths).
The substance is mildly toxic by inhalation.

Justification for selection of acute toxicity – dermal endpoint
The dermal LD50 value of the substance in rats amounted to 569 mg/kg bw for the sexes combined.
In a supporting study, there was clear evidence of skin corrosion.
Based on the results, and according to EU Directive 67/548/EEC, Polycat 77 should be classified as harmful to the skin.

Justification for classification or non-classification

Based on the result of studies and according to the criteria of the CLP Regulation the substance should be classified as category 4 acute oral toxicant, H302 and category 3 acute dermal toxicant, H311. According to the criteria of the DSD Regulation, the substance is classified as Xn R22 and Xn R21, respectively. The substance should not be classified for acute toxicity via inhalation routes according to the DSD and CLP criteria.